Sarepta Therapeutics Inc. (SRPT) announced that it has initiated dosing its first patient in a phase I/II study on SRP-4053.
The candidate is being evaluated for Duchenne muscular dystrophy (DMD). This multiple-dose study will be conducted at four sites in Europe under a consortium agreement between the company and numerous European hospitals, institutions and scientists to assess the safety, tolerability, efficacy and pharmacokinetics of SRP-4053 in DMD patients with genotypes amenable to exon-53 skipping.
The study will be partly funded by the EU’s Seventh Programme for research, technological development and demonstration under grant agreement no. 305370.
A devastating and incurable muscle-wasting disease, DMD is one of the most common fatal genetic disorders affecting children around the world. There is significant unmet need for DMD treatments.
Earlier in the week, Sarepta announced data through week 168 from a phase IIb open-label extension study (study 202) on its lead candidate eteplirsen, in DMD patients. Although the results of a 6-minute walk test at 168 weeks showed continued ambulation across all patients after more than three years of treatment, they showed a decline in distance walked on this measure since week 144. Consequently, shares of Sarepta fell 14.6%.
We note that Sarepta currently does not have any approved product in its portfolio. Successful development and commercialization of eteplirsen is crucial for the company. We expect investor focus to remain on updates pertaining to eteplirsen.
Sarepta currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader health care sector include Biodel, Inc. (BIOD), AMAG Pharmaceuticals, Inc. (AMAG) and Alexion Pharmaceuticals, Inc. (ALXN). All three carry a Zacks Rank #1 (Strong Buy).
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